Quantitative analysis of maytansinoid (DM1) in human serum by on-line solid phase extraction coupled with liquid chromatography tandem mass spectrometry - Method validation and its application to clinical samples

Journal of Pharmaceutical and Biomedical Analysis

Volumn 120, Issue , 2016, Pages 322-332

  Heudi, Olivier ^a   Barteau, Samuel ^a   Picard, Franck ^a   Kretz, Olivier ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Antibody drug conjugate; LC MS MS; Maytansinoid; On line SPE and human serum

Indexed keywords

DRUG ANTIBODY; MAYTANSINOID; N ETHYLMALEIMIDE; REDUCING AGENT; TAXOID; THIOL; TRIS (2 CARBOXYETHYL)PHOSPHINE; UNCLASSIFIED DRUG; EMTANSINE; MAYTANSINE;

ANALYTIC METHOD; ARTICLE; CONTROLLED STUDY; DIMERIZATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID CHROMATOGRAPHY; MASS SPECTROMETER; MEASUREMENT ACCURACY; PARTICLE SIZE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION; SOLID TUMOR; TANDEM MASS SPECTROMETRY; VALIDATION STUDY; ANALOGS AND DERIVATIVES; BLOOD; INTRAVENOUS DRUG ADMINISTRATION; NEOPLASMS; PROCEDURES; REPRODUCIBILITY; STANDARDS;

CHROMATOGRAPHY, LIQUID; HUMANS; INFUSIONS, INTRAVENOUS; MAYTANSINE; NEOPLASMS; REPRODUCIBILITY OF RESULTS; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY;

EID: 84952887089     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2015.12.026     Document Type: Article

References (18)

1. Beck A., Reichert J.M. Antibody-drug conjugates. mAbs 2013, 6:15-17.
2. Lambert J.M. Drug-conjugated monoclonal antibodies for the treatment of cancer. Curr. Opin. Pharmacol. 2005, 5:543-549.
3. Wu A.M., Senter P.D. Arming antibodies: prospects and challenges for immunoconjugates. Nat. Biotechnol. 2005, 23:1137-1146.
4. Lewis Phillips G.D., Li G., Dugger D.L., Crocker L.M., Parsons K.L., Mai E., Blattler W.A., Lambert J.M., Chari R.V., Lutz R.J., Wong W.L., Jacobson F.S., Koeppen H., Schwall R.H., Kenkare-Mitra S.R., Spencer S.D., Sliwkowski M.X. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008, 68:9280-9290.
5. DiJoseph J.F., Goad M.E., Dougher M.M., Boghaert E.R., Kunz A., Hamann P.R., Damle N.K. Potent and specific antitumor efficacy of CMC-544, a CD22-targeted immunoconjugate of calicheamicin, against systemically disseminated B-cell lymphoma. Clin. Cancer Res. 2004, 10:8620-8629.
6. Wahl A.F., Klussman K., Thompson J.D., Chen J.H., Francisco L.V., Risdon G., Chace D.F., Siegall C.B., Francisco J.A. The anti-CD30 monoclonal antibody SGN-30 promotes growth arrest and DNA fragmentation in vitro and affects antitumor activity in models of Hodgkin's disease. Cancer Res. 2002, 62:3736-3742.
7. Ojima I., Geng X., Wu X., Qu C., Borella C.P., Xie H., Wilhelm S.D., Leece B.A., Bartle L.M., Goldmacher V.S., Chari R.V. Tumor-specific novel taxoid-monoclonal antibody conjugates. J. Med. Chem. 2002, 45:5620-5623.
8. Kaur S., Xu K., Saad O.M., Dere R.C., Carrasco-Triguero M. Bioanalytical assay strategies for the development of antibody-drug conjugate biotherapeutics. Bioanalysis 2013, 5:201-226.
9. Sanderson R.J., Hering M.A., James S.F., Sun M.M.C., Doronina S.O., Siadak A.W., Senter P.D., Wahl A.F. In vivo drug-linker stability of an anti-CD30 dipeptide-linked auristatin immunoconjugate. Clin. Cancer Res. 2005, 11:843-852.
10. Tolcher A.W., Ochoa L., Hammond L.A., Patnaik A., Edwards T., Takimoto C., Smith L., De Bono J., Schwartz G., Mays T., Jonak Z.L., Johnson R., DeWitte M., Martino H., Audette C., Maes K., Chari R.V.J., Lambert J.M., Rowinsky E.K. Cantuzumab mertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study. J. Clin. Oncol. 2003, 21:211-222.
11. Shen B.Q., Bumbaca D., Saad O., Yue Q., Pastuskovas C.V., Khojasteh S.C., Tibbitts J., Kaur S., Wang B., Chu Y.W., LoRusso P.M., Girish S. Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine (T-DM1): an emphasis on preclinical and clinical catabolism. Curr. Drug Metab. 2012, 13:901-910.
12. Poon K.A., Flagella K., Beyer J., Tibbitts J., Kaur S., Saad O., Yi J.H., Girish S., Dybdal N., Reynolds T. Preclinical safety profile of trastuzumab emtansine (T-DM1): mechanism of action of its cytotoxic component retained with improved tolerability. Toxicol. Appl. Pharmacol. 2013, 273:298-313.
13. Wei D., Sullivan M., Espinosa O., Yang L. A sensitive LC-MS/MS method for the determination of free maytansinoid DM4 concentrations-method development, validation, and application to the nonclinical studies of antitumor agent DM4 conjugated hu-anti-Cripto MA b B3F6 (B3F6-DM4) in rats and monkeys. Int. J. Mass Spectrom. 2012, 312:53-60.
14. Gupta M., Lorusso P.M., Wang B., Yi J.H., Burris H.A., Beeram M., Modi S., Chu Y.W., Agresta S., Klencke B., Joshi A., Girish S. Clinical implications of pathophysiological and demographic covariates on the population pharmacokinetics of trastuzumab emtansine, a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer. J. Clin. Pharmacol. 2012, 52:691-703.
15. Burris H.A., Rugo H.S., Vukelja S.J., Vogel C.L., Borson R.A., Limentani S., Tan-Chiu E., Krop I.E., Michaelson R.A., Girish S., Amler L., Zheng M., Chu Y.W., Klencke B., O'Shaughnessy J.A. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J. Clin. Oncol. 2011, 29:398-405.
16. Krop I.E., Beeram M., Modi S., Jones S.F., Holden S.N., Yu W., Girish S., Tibbitts J., Yi J.H., Sliwkowski M.X., Jacobson F., Lutzker S.G., Burris H.A. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J. Clin. Oncol. 2010, 28:2698-2704.
17. Mallett D.N., Ramirez-Molina C. The use of partially porous particle columns for the routine, generic analysis of biological samples for pharmacokinetic studies in drug discovery by reversed-phase ultra-high performance liquid chromatography-tandem mass spectrometry. J. Pharm. Biomed. Anal. 2009, 49:100-107.
18. Heudi O., Barteau S., Zimmer D., Schmidt J., Bill K., Lehmann N., Bauer C., Kretz O. Towards absolute quantification of therapeutic monoclonal antibody in serum by LC-MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry. Anal. Chem. 2008, 80:4200-4207.